Reported suspected adverse drug reactions to

coronavirus vaccines
About the report:
 A summary is presented below of all processed reports concerning suspected adverse
reactions following coronavirus vaccination from 27 December 2020, the date on which the
first vaccine became available.
 The figures are taken from the ADR Registry and include reports from health professionals,
the general population and vaccine manufacturers in Norway.
 Only reports, which have undergone quality assurance and have been processed in the ADR
Registry are included in the report. At any time, there will be reports that are being
processed – these reports are not included in this summary.
 Reports of serious events are processed first. The report therefore does not give a true
picture of the distribution between serious and non-serious events at any one time.
 Symptoms or illnesses that occur after vaccination are reported if there is any suspicion of a
possible link. As a result, no causal link between the suspected adverse reaction and the
vaccine has been established.
 This report contains all processed reports of suspected adverse reactions regardless of any
possible causal link.
 The data concerning the various coronavirus vaccines are not directly comparable. This is
partly because they have different adverse reaction profiles, because they were punt into
use at different time points and because the vaccines have been administered to different
numbers of people with different disease profiles and ages.
 The distribution between age and gender must be viewed in the context of the gender and
age distribution amongst those who have been vaccinated.
 Each report is assessed on an ongoing basis, and weekly reports are published with a
summary of adverse reactions that have been reported following vaccination with the
coronavirus vaccines.

Summary
The reports do not provide a basis for revising the current recommendations regarding the
use of the coronavirus vaccines. The benefits of administering the vaccine are expected to
outweigh the risks.
There are currently no new signals of unexpected or serious adverse reactions in Norway.
The suspected adverse reactions, which have been observed following vaccination, are
generally in line with the product information.
Most of the reports relate to known adverse reactions, such as transient malaise, fever,
fatigue, nausea and body pain. These usually appear on the first or second day after
vaccination and last around 2-3 days. The vast majority of those who have been vaccinated
appear to have suffered no adverse reactions.
Amongst the reports that have been processed, there were 30 deaths with a temporal
relationship to vaccination. In several of these, the reporter states that no relationship to
vaccination is suspected. The fact that some nursing home residents die soon after being
vaccinated does not imply that there is a causal relationship. In order to analyse whether
there could be a causal relationship, other data and advanced analyses are normally
required.
For some of the patients, it cannot be ruled out that relatively mild adverse reactions
following the vaccination of frail elderly people contributed to a more severe course in their
general condition or underlying illness, leading to death of the patient.

Coronavirus vaccines in use in Norway

Two coronavirus vaccines are approved for use in Norway: Comirnaty (BioNTech/Pfizer) and COVID-
19 Vaccine Moderna (Moderna). Both are mRNA vaccines, given in two doses a few weeks apart.

Statistics concerning reports of suspected adverse reactions

as of 26.01.2021
To date, 391 reports of suspected adverse reactions following coronavirus vaccination have been
received, where 150 of these have been processed, following the vaccination of approximately
80,000 people with a coronavirus vaccine.

Distribution of reports by gender

Gender Female Male
Number 113 37
Table 1: Gender breakdown amongst patients in the reports

Distribution of reports by age

Age group
18-39 40-59 60-69 70-79 80-89 90+ Unknown
age
25 14 5 19 40 43 4
Table 2: Age distribution of patients in the reports
Residents in nursing homes, persons 85 years of age and older, and selected groups of
healthcare professionals and other employees in the health and care services have so far
been given priority in the vaccination programme. This is also reflected in the gender and
age distribution of the patients in the reports.
The weekly report at FHI.no shows the number and proportion of persons vaccinated in
different age groups and gender distribution nationwide.
Distribution of reports by severity for each of the vaccines
Comirnaty (Pfizer/BioNTech)
Total number of Number of reports Reports of serious events Reports of non-serious
reports involving death other than death events
146 33 25 88
Table 3: Distribution of reports of suspected adverse reactions according to severity for
Comirnaty
Covid-19 Vaccine Moderna (Moderna)
Total number of Number of reports Reports of serious events Reports of non-serious
reports involving death other than death events
4 0 0 4
Table 3: Distribution of reports of suspected adverse reactions according to severity for
Covid-19 Vaccine Moderna

Reported events following vaccination are classified as serious when:

 the event resulted in/extended a stay in hospital
 the event is considered to be a medically important event
 the event resulted in a prolonged reduction in function level
 the event resulted in a life-threatening illness (e.g. anaphylaxis) or death.
 the event resulted in birth defects/congenital malformations

Reports on death
Per 26.01.2021, 33 reports involving deaths of nursing home residents have been processed.
Many of the nursing home residents who have been vaccinated so farare very frail or
terminally ill patients. Every day, an average of 45 people die in Norwegian nursing homes
or other similar institutions. Therefore, deaths that occur close to time of vaccination is
expected, but it does not imply a casual relationship to the vaccine. The reported deaths
have occurred within a period of 1-12 days following vaccination.
In several of the fatal reports, the reporter states that no link with vaccination is suspected,
and that the death is being reported for the sake of completeness. Many of the patients
were also frail prior to vaccination. However, in the case of some of the most frail patients,
it cannot be ruled out that relatively mild adverse reactions following vaccination
contributed to a more severe course in their general condition or underlying illness, leading
to death of the patient..
These individual case reports do not currently constitute a signal of a new adverse reaction
and therefore do not provide a basis for revising the product information for the vaccine.
Number of suspected adverse reactions according to category
A single adverse reaction report can include a number of suspected adverse reactions or
symptoms. Table 4 show suspected adverse reactions grouped according to the category to
which they belong and the types of suspected adverse reactions which have been reported
most frequently.
The distribution is categorised according to the origin of the suspected adverse reaction
(e.g. the heart), or the cause of the suspected adverse reaction (e.g. infections). The
categories are the highest level in a hierarchical, standardised medical terminology, which is
used internationally (MedDRA). Using this terminology makes it possible compare reports
internationally.

Category Number of
reported adverse
reactions
General symptoms and reactions at the vaccine administration site 141
E.g.: Pain around the injection site, discomfort, fever, fatigue
Gastrointestinal symptoms 52
E.g.: Stomach pain, nausea, vomiting, diarrhoea
Neurological symptoms 46
E.g.: Headache, dizziness, drowsiness
Respiratory tract symptoms 43
E.g.: Difficulty breathing, shortness of breath, cough, irritation of the
respiratory tract
Musculoskeletal symptoms 28
E.g.: Muscle pain, joint pain, muscle stiffness
Examinations 12
E.g.: Abnormal pulse, reduced blood pressure
Psychiatric symptoms 8
E.g.: Sleep abnormalities, restlessness, lethargy, anxiety
Skin symptoms 8
E.g.: Rash, itching, redness
Infections 7
E.g.: Pneumonia
Cardiac symptoms 7
E.g.: Abnormal heart rate
Metabolic and nutrition-related symptoms 6
E.g.: Reduced appetite
Vascular symptoms 6
E.g.: Flushes, pallor
Eye symptoms 4
E.g.: Blurred vision
Kidney and urinary tract symptoms 2
E.g.: Urinary tract infection
 Immune system symptoms 2
E.g.: Allergic reaction
Ear symptoms 1
E.g.: Discomfort in the ear
Table 4: Reported suspected adverse reactions broken down by category of mRNA vaccine
The most frequently reported symptoms primarily consist of known adverse reactions
within the general symptoms category, and include reactions at the vaccine injection site,
decreased general condition, fever and general malaise. Gastrointestinal symptoms such as
diarrhoea, nausea and vomiting have also been reported, as well as neurological symptoms
such as headaches and dizziness. The symptoms have arisen within 1-2 days after
vaccination and have generally disappeared within a few days.